Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Chengdu Suncadia Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Treatments: Drug: HRS-5965 Capsules; Drug: HRS-5965 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06238544

HRS-5965-203

Details and patient eligibility

About

This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.

Exclusion criteria

1. Known or suspected hereditary or acquired complement deficiency;
2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

HRS-5965 Group

Experimental group

Treatment:

Drug: HRS-5965 tablets

Drug: HRS-5965 Capsules